Three Dimensional Conformal Radiotherapy / Intensity Modulated Radiotherapy Alone Vs Three Dimensional Conformal Therapy / Intensity Modulated Radiotherapy Plus Adjuvant Hormonal Therapy In Localized T1b-c, T2a, N0, M0 Prostatic Carcinoma. A Phase III Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 819
- 试验地点
- 40
- 主要终点
- Biochemical and clinical disease-free survival as measured by Logrank prostate-specific antigen progression every 6 months until year 5, and annually thereafter
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bicalutamide and goserelin may fight prostate cancer by reducing the production of testosterone. It is not yet known if radiation therapy is more effective with or without bicalutamide and goserelin in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide and goserelin in treating patients who have localized prostate cancer.
详细描述
OBJECTIVES:
- Compare the potential beneficial impact of radiotherapy with or without adjuvant bicalutamide and goserelin on the long-term outcome of patients with localized prostate cancer.
- Compare the acute and late radiation-induced side effects of these regimens in these patients.
- Compare the biochemical/clinical disease-free survival, overall survival, and time to local progression in patients treated with these regimens.
- Compare the time to clinical biological failure or death in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor class (T1b-c vs T2a), initial prostate-specific antigen level (10 ng/mL vs 10-20 ng/mL vs greater than 20 ng/mL), Gleason score (2-6 vs 7-10) and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo 3-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for 7-7.5 weeks.
- Arm II: Patients receive adjuvant oral bicalutamide once daily on days 1-30 and goserelin subcutaneously on days 8 and 98. Beginning on day 8, patients undergo radiotherapy as in arm I.
Quality of life is assessed at baseline and then at months 6, 12, 24, and 36.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Biochemical and clinical disease-free survival as measured by Logrank prostate-specific antigen progression every 6 months until year 5, and annually thereafter
次要结局
- Late toxicity as measured by EORTC and RTOG every 6 months until year 5, and annually thereafter
- Overall survival as measured by Logrank every 6 months until year 5, and annually thereafter
- Acute toxicity as measured by NCI-CTC v2.0 up to 1 month post radiotherapy
- Clinical disease-free survival as measured by Logrank every 6 months until year 5, and annually thereafter
- Local control as measured by Gray scale every 6 months until year 5, and annually thereafter
- Quality of life as measured by EORTC QLQ-C30 and EORTC PR-25 every 6 months until year 5, and annually thereafter